Arteriopathy and Endothelial Function

February 24, 2009 updated by: University Hospital, Strasbourg, France

Endothelial Dysfunction Reversibility in Patients With Peripheral Arterial Disease

To determine whether fruit juice might reverse endothelial dysfunction and whether this reversibility has a prognosis value

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Chirurgie Vasculaire
        • Contact:
        • Principal Investigator:
          • Fabien Thaveau, MD
        • Sub-Investigator:
          • Nabil Chakfe, MD
        • Sub-Investigator:
          • Jean-Georges Kretz, MD
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Physiologie et d'Explorations Fonctionnelles
        • Contact:
        • Principal Investigator:
          • Olivier Rouyer, MD
        • Sub-Investigator:
          • Bernard Geny, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Peripheral arteriopathy
  • Stable cardio-respiratory status

Exclusion Criteria:

  • Dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fruit juice
300 mL of fruit juice
Procedure: Fruit juice or placebo absorption
absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.
Placebo Comparator: placebo
300 mL of fruit juice without polyphenols
Procedure: Fruit juice or placebo absorption
absorption of 300 ml of fruit juice ; 24 hours later, absorption of 300 ml of placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial function 1 hour after taking the juice
Time Frame: 1 hour after taking the juice
1 hour after taking the juice

Secondary Outcome Measures

Outcome Measure
Time Frame
Relationship between reversibility of the endothelial function and the patient's prognosis at 3 years
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Study Director: Olivier Rouyer, MD, Hopitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

June 15, 2007

First Submitted That Met QC Criteria

June 15, 2007

First Posted (Estimate)

June 18, 2007

Study Record Updates

Last Update Posted (Estimate)

February 25, 2009

Last Update Submitted That Met QC Criteria

February 24, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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